- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04209998
New Oxymetry Indices in Critical Limb Ischemia (NOVICE)
New Oxymetry Indices in Critical Limb Ischemia (French Original Title is "Nouveaux Indices Oxymétriques Chez Les Patients Vus Pour Suspicion d'Ischémie Critique du membrE inférieur")
Transcutaneous oxygen tension (TcpO2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (CLI). If foot TcpO2 measurements are good prognostic factors of the risk of amputation or the probability of wound healing without amputation, they have never proven their hability to estimate the risk of death in patients with critical limb ischemia. On the one hand, studies have considered only the response observed on legs without considered the thoracic variations. On the other hand, the variability of the TcpO2 signal has never been analyzed as a prognostic factor.
The objective of the NOVICE study is therefore to assess, first, whether the variability of resting TcPO2 values at thoracic probe as well as at affected limb probe is a morbidity-mortality prognostic factor and secondly, to evaluate during the oxygen tests, if the measurement of the amplitude of the distal responses in ischemic zone compared to the response observed in thoracic probe is a prognostic factor of morbi-mortality.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49933
- Centre Hospitalier Universitaire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspicion of Critical limb ischemia
- Reffered for Tcpo2 Absence of rebuttal to the use of the data by the patients
Exclusion Criteria:
- No available tcpo2 recording
- Rejection of the follow up by the patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 12 months
|
presence of MACE (major adverse cardiovascular event) following the oximetry test
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity
Time Frame: 12 moths
|
presence of MALE (major adverse lower limb event) following the oximetry test
|
12 moths
|
Mortality (intermediate analysis)
Time Frame: 6 months minimal follow-up
|
Mortality all causes (intermediate analysis prior to Covid interference)
|
6 months minimal follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ABRAHAM Pierre, MD PhD, University Hospital in Angers
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A02619-48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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